Bonus CD-ROM Available! See Back Cover for More Details The Science an - Practice of Ph 21st EDITII, is 24sT EDITION Remington The Science and Practice of Pharmacy (ium WOAZ-F33-GD4 9Editor: David B. Troy ‘Managing Editor, Matthew J. Hauber Marketing Manager: Marisa A. O'Brien Lippincott Williams & Wilkins 51 West Camden Stroot Baltimore, Maryland 21201-2436 USA 530 Walnut Strost Philadelphia, PA 19106 All rights reserved. This book is protected by copyright. No part ofthis book may be reproduced in any form or by any means, including photocopying, or utilized by any information storage and retrieval system without written permission from the copy- right owner. ‘The publisher is not responsible (as a matter of product liability, negligence or otherwise) for any injury resulting from any ‘material contained herein, This publication contains information relating to general principles of medical eare which should not be construed as specific instructions for individual patients. Manufacturer's product information and package inserts should be reviewed for current information, including contraindications, dosages and precautions. Printed in the United States of America Entered according to Act of Congress, in the year 1885 by Joseph P Remington, in the Office ofthe Librarian of Congress, at Washington DC Copyright 1889, 1894, 1905, 1907, 1917, by Joseph P Remington Copyright 1926, 1936, by the Joseph P Remington Estate Copyright 1948, 1951, by the Philadelphia College of Pharmacy and Science Copyright 1956, 1960, 1965, 1970, 1975, 1980, 1985, 1990, 1995, by the Philadelphia College of Pharmacy and Science Copyright 2000, 2006, by the University of the Sciences in Philadelphia All Rights Reserved Library of Congress Catalog Card Information is available ISBN 0-7817-4673-6 ‘The publishers have made every effort to trace the copyright holders for borrowed material. If they have inadvertently overlooked ‘any, they will be pleased to make the necessary arrangements at the first opportunity. The use of structural formulas from USAN and the USP Dictionary of Drug Names is by permission of The USP Convention. The Convention is not responsible for any inaccuracy contained herein. Notice—This text in not intended to represent, nor shall it be intorproted to be, the equivalent ofor @ subslitute for the officiel United States Pharmacopeia (USP) and/or the National Formulary (NB). In the event of any difference or discrepancy between the ‘current official USP or NF standards of strength, quality, purity, peckaging and labeling for drugs and representations of them herein, the context and effect ofthe official compendia shall prevail. ‘To purchase additional copies of this book call our customer service department at (800) 638-8030 or fax orders to (301) 824-7390. International customers should call (901) 714-2824. 2845678910Contents 1 Orientation 1 Scape of Pharmacy 3 2 Evolution of Pharmacy 7 3 thes and Protesienatism 20 4 ThePracice of Community Prarmacy 30 5 Phamacsts in Industry 35 5 Pharmacstsin Government 40 7 Pharmacsts and Public Heath 51 2 Infermation Resources in Pharmacy and the Pharmaceutical Sciences 64 2 Circa orug tteraiure 74 10 Research 87 Part 2__ Pharmaceutics 11 Metrology and Pharmaceutical Calulations 99 Ta eT 13 Molecular Structure, Properties, and States of Matter ...162 14 Complex Formation 186 15 Thermodynamics 201 16 Solutions and Phase Equlibria. 20 17_Toné Solutions and Electrolytic Equilibria 231 18 Toniity, Osmoticty, Osmolaliy, ad Osmolanty 250 19 Chemica Kinetics 266 20 Interfacial Phenomena 280 21 Coloidaliepersions 293 22 Course Dispersions 319 23 Rheology 338 Part 3__ Pharmaceutical Chemistry 24 Inorganic Pharmaceutical Chemisty 361 25___Organic Pharmaceutical Cheristry 386 26 Naualmodes 27 Drug Nomendature—Unted States Adooted Names 443 28 Structure-Actty Relationship and Orug Design 468 29 Fundamentals of Nedica Radionucides 479 ‘Analysis of Medcinals 495 Biological Testing 353 Clinical Analysis 565 Chromatography 599 Instumental Methods of Anaysis 633 35 Dissolution 672 Part Pharmaceutical Manufacturing 36 Separation 691 37 Powders 702 38 Property Based Drug Design and Preformulation . 720 39___ Solutions, Emulsiors, Suppensons, and Bxracts 745 40 Steilizaton 776 41° Parenteral Preparations 802 42 Intravenaus Admidures 37 43, Ophthalmic Preparations 250 44 Medicated Topicals a7 45 Oral Sold Dosage Forms 889 46 Costing of Pharmaceutical Desage Forms 928 47__Extendie-nelease and Targeted brug Delivery systems 939 48 TheNew Drug Approval Process ard Clinical Trial Cesign 965 49. Biotechnology and Drugs 976 50 Aerosols 1000 St Quality Assurance and Control 1018 52___ Stability of Pharmaceutical Producte 1025 53 Bioavalabity and Bioequialency Testing 1037 5a Plast Packaging Materials 1047 Pharmaceutical 10 Part6 Pharmacokinetics and Pharmacodynamics Diseases: Manifestations and P io 1085 57 Drug Abserption. Acion, and bispostion| Tad 58 Basic Pharmacokinetics and Pharmacodynamics 171 59 Cinial Pharmacokinetics and Pharmacodynames 1194 60 Principles of Immunology 1206 61 Adverse Drug Reactions and Clinical Toxicology 12 62 Pharmacogenomics 1230 63 Pharmacolinetic/Pharmacodyramics in rug Development 1249 Part7__ Pharmaceutical and Medicinal Agents 64 Diagnostic Drugs and Reagents : 1261 65 Topical Orgs 1277 66 Gastointestinal and Liver Drugs 1294 67 Blood, Fluids, Electives, and Hematologcal rugs 1318. 68 Cardovascular rugs 1350 69 Respratory Drugs 1371 70 Sympathomimetic Drugs 1379, 71 Choinomimetic rugs 1389 72 Adrenergic Antagonsts and Ackenergic Neuron Blocking Orugs ce 1399 73 Antimuscarnic and Antisposmodie O-ugs 1405 7a Skeletal Muscle Relaxants ant 75 Diuretic Dugs 1322 78 Uterine ard Animigraine Drugs 1432 77 Hormones and Hormone Antagonists 1437 78 General Anesthetics, 1474 79 Local Anesthetics 4479 80 Antiansety Agents and Hypnotic Drugs 1486, 81 Antiepileptc Drugs 1501 82 Paychopharmaclogie Agents 1509 83 Analgesic, Antipyretc, and Antrinfiammatory Drugs. ..1524 184 Histamine and Antinstamnic Drugs 1543 85 Centval Nervous System Simulants 1551 86 Antineoplastic Drugs 1556 87 _immunoactve rugs 1588 88 Parasticides 1595, 89 immunizing Agents and Allergen Extracts 1600 90 Antiinfecives 1526 91 Enzymes 1605 92 Nutrients and Associated Substances, 1688 93 Pestkides a9 Part® Pharmacy Practice ‘A. Fundamentals of Pharmacy Practice 94 ___ Application of Ethical Principles to Practice Dilemmas 1745 95 Technology and Automation 1753 ‘36 “The Patient Rehavioal Determnanis 1762 ‘97 Patient Communication 70 98 Patient Conplance 1782 99° Drug Education 1796 vod2a 100 104 105 106 108 109 no m2 na 14 16 ‘CONTENTS Professional Communications ‘The Prescription Providing a Framework for Encuring Medication Use Safety Faison Contol Drug Ineracions txeemporaneous Prescription Compounding ‘Nuclear Pharmacy Practice Nutrition in Pharmacy Practice Pharmacoendemioiogy Surgica Supplies Health Accesories B Social, Behavioral, Economic, and ‘Administrative Sciences Laws Goverring Pharmacy Re-engineering Pharmacy Practice Prarmacosconomice ‘Community Pharmacy Economics and Managernent Product Recalls ard Withdranals ‘Marketng Pharmaceutical Care Sevices 1808 1823 18a) 1881 1889 1903 1913 1925 1958 1968 1979 2015 2055 2070 2082 2098 2107 7 119 120 121 12 13 124 125 126 127 128 123 130 131 i 133 Documenting, Bling, and Reimbursement for Pharmaceutical Care Senices Pharmaceutical Risk Managerront Integrated Health Care Delivery Sysiems © Patient care Specialization in Pharmacy Practice Pharmacéts ard Disease State Management Development ofa Pharmacy Care Pan and Patent Problem-Solving ‘Amaulatory Patient Care Self-Care Diagnoste Set.care Preventive Care Hospital Pharmacy Practice Emergency Medicine Pharmacy Practice Long-Tern Care - Aseptic Processing for Home Infusion Pharmaceuticals Te Pharmacis's Role in Substance Use Disorders Complementary and Alternative Metical Health Care Chronic Wourd Care aa D24 2130 2155 2163 2170 2179 2197 2206 2223 2247 2265, 2272 2290 2303 218 2342aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.PHARMACY PROFESSIONAL DEGREE PROGRAMS ‘The following colleges and schools offering professional degree programs in pharmacy hold membership in the ACP. Alsbama Auburn University, Harrison Schocl of Pharmacy, ‘Aubur University, AL 36849 Samford University, MeWhorter Scheol of Pharmacy, Birmingham, AL 35229 Arizona, Midwestern University, College of Pharmacy. Glendale, Glendale, AZ 85808 University of Arizona, Colege of Pharmacy, Tueson, AZ Arkansos University of Arkansas for Medical Sciences, College ‘of Pharmacy, Lite Rec, ARR 72205, California University of California, San Francisco, School of Pharmacy, San Francisco, CA 94143, University of the Pacific, Thomas J. Long School of Pharemacy end Health Sciences, Stockton, CA 95211, University of Scuthern California, School of Phar- racy, Los Angeles, CA 90089 ‘Western University of the Health Sciences, Collage of Pharmacy, Pomona, CA 91766 Loma Linda University, School of Pharmacy, Loma Tinda, CA #2350 University of California, San Diogo, School of Phar- ‘macy and Pharmaceatical Sciences, La Jolla, CA 2088 Colorado University of Colorado, Health Sciences Center, School of Pharmacy, Denver, CO 8022 Connecticut University of Connecticut, Schoo! of Pharmacy, Storrs, cr 0626s Districtof Howard University, College of Pharmacy, Nursing Cohimba and Allied Health Scieneor, Washington, LC 20089, Flerida Florida Agricultural and Mechanical University, Col luge of Pharmacy and Pharnaceatical Science, Talla. hase, FL 32807 Nova Southeastern University, College of Pharmacy, Fort Lauderdale, FL 33528 Palm Beach Atlantic Univesity, School of Pharmacy, West Palm Beach, FL 33415 University of Florida, College of Pharmacy, Gainesville, FL $2610 Georgia Mercer University, Southern Sehoo! of Pharmacy, At- lanta, GA'30341 University of Georgia, College of Pharmacy, Athens, GA.30502 Idaho Idaho State University, College of Pharmacy, Pocatello, 1D 88208 Miinois Midwestern University, Chicago College of Pharmacy, Downers Grove, IL 60515 University o Minos at Chicago, Collegeof Pharmacy, Chicago, 1.60612 Indiana Butler University, Cellege of Pharmacy and Health Purdue University School of Pharmacy and Pharma ‘eal Beionces, West Lafayette, IN47007 Towa Drake University, Cllege of Pharmacy and Health ‘Seencos, Des Mines, TA 60311 University oflowa, College of Pharmacy, lowa City, 1A Kansas University of Kansas, School of Pharmacy, Lawrence, ‘0043 Kentucky University of Kentuehy, Collegeof Pharmacy, Lexing: ten, 40536 Louisiana University of Louisiana at Monroe, Schoo! of Phar. macy, Monme, LA 71209 Xavier University of Louisiana, College of Pharmacy, ‘New Orleans, LA 70125, Maryland University of Maryland, Schoo! of Pharmacy. Balt more, MD 21201 Massachusetts Michigan Minnesota Mississppl Missour Montana Nebraska Nevada Newdersey New Mexico New York North Carolina North Dakota, Obie Oklahoms Oregon Pennsylvania Prerto Rico (CHAPTER t: SCOPE OF PHARMACY 5 Massachusetts College of Pharmacy, and Health Sciences Boston Campus, Boston, MA C2115 Massachusetts College of Pharmacy and Health Scionces Worcester Campus, Worcester, MA 1610, Northesstorn University, School o Pharmac, ston, MAO2I05 Ferris State University, College of Pharmacy, Big Rapid, MI 49807 University of Michigan, College of Pharmacy, Ane Ar bor ME A808 Wayne State University, Bagone Applebaum Colege of Pharmacy and Health Seienees, Detroit, MI 48202 Univernty of Minnesota, Calle of Pharmacy, Bie neapols, MN 5 Univers of afassspp, School of Paarmaey, Uni versity, MS 38655 St Louis Collegeof Pharmacy, St Louis, MO 63119 University of Missouri-Kansas City, School of Phar- racy, Kanone Cis, MOBA110 University of Montana, School of Pharmacy and Aled Health Science, Missoula, NT 59812, Creighton Universit, School of Pharmacy nd Health Prafessins, Omaka, NE 6817S University of Nebraska Medien! Contor, College of Pharmasy, Omaha, NE 68198 University ofSouthorn Nevada, Henderson, XV 89014 Rutgers, the State University of New Jersey, Ernest Mario College of Pharmacy, Pieatatay, NU DB854 University of New Mexico, Collegeof Pharmacy, Alba queue, NAESETSD Union University, Albany College of Pharmacy, Al tay, NY 1208 Long Island University, Armld and Marie Schwartz College of Pharmacy and Health Sciences, Brooklyn, NYT St John's University, Cllege of Pharmacy and Aled Heath Professions damaica, NY 11438 Site Univesity o'ew York at Bull, Shoal of Phar= ‘macy and Pharmaceutical Sciences, Amberst, NY 14260 Campbell University, Scheo! of Pharmacy, Buies Creek, NC 27506 Univesity of North Carolina at Chape Hill, Schol of Pharmacy, Chapel Hill. NC 27598 North Dakota State Universty, Callege of Pharmacy, Fargo, ND 58108 Ohio Northern University, RAH. Raabe Collegy of Pharmacy, Ade, O4 45810 ‘The Ohio State University, College of Pharmacy, Catumtan, OF 42210 University ofCincinnat, College a Pharmacy, Ciein- tat OH 45957 University of Toledo, Cllegeof Pharmacy Tledo,OH Southwestern Oklahoma State University, School of Pharmasy, Weatherford, OR 709 University of Oklahoma, Callege of Pharmacy, Okla- homa City, OK 75190 Oregon State University, College of Pharmacy, Cor- vais, OR 97551 Dunuesne University, Mylan School of Pharmacy, Pitsburgh, PA 15282 Lake Erie Clloge of Osteopathic Medicine, School of Pharma. Ere, PA 16309 ‘Temple University, Schl of Pharmacy, Philadelphia, Paibna University ofPituburgh, School of Pharmacy, Pat: burgh, PA 15061 University ofthe Sciences in Philadephia, Philadel ‘hin Calloge of Pharmacy, Philadephie, PA 1910¢ Wilkes University, Nesbitt School of Pharmacy Wikes-Barve PA L766 University af Puerto Ric, Scho! of Pharmacy, San ‘Jaan, PRON =aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.essentially seperate, Cast to their own devices, monks put together their own short versions of classical medical texts (epitomes) and planted gardens to grow the medicinal herbs that were no longer available after the collapse of trade and commerce. Strong in their faith, these amateur healers tended to ascribe their cures to the will of God, rather than to their ‘meager medieal resources. ‘As Western Europe struggled, a new civilization arose among. those who fillowed the teachings of Mohammed (670-692), The formerly nomadie peoples who united into the nations of Islam conquered huge areas of he Middle East and Africa, eventually expanding into Spain, Sicily, and Eastern Europe. Becausethei fiath taught them to respect the written word and those whe studied it, they tolerated the scholarship of the Christian sec tarians whohad led persecution inthe Eastern Roman Empire, the Nestorians, for example, established a famous school in Gondeshapur in the 6th century. ‘Among the Islamic nations, Greek writings. including those dealing with medicine, were translated into Arabic. At first the ‘Arabs accepted the authority of Greek medieal writings totaly, ‘especially those of Galen and Dioscorides. But as their sophis- ‘ication grew, Islamic medical men like Rhazes (860-032) and Avicenna (980-1063) added to the writings of the Greeks. The far-flung trading outposts ofthe conquering Arabs also brought new drags and spices to the centers of learning. Moreover, Arab physicians rejected the old idea shat foul-tasting medicines ‘worked best. Instead, they devoted a great deal of effort tomak- ing their dosage forms elegan: and palatable, through the sil ‘vering and gilding of pills and the use of syrups. “The new, more sophisticated medicines required elaborate preparation. In the cosmopolitan city of Baghdad of the 9th cen- fury, this work was taken over by specialists, the occupational ancestors of today’s pharmacists. In places such as Spain and southern Italy where the Islamic world interacted most with Feeovering western Europe, several of the institutions and developments of the more highly developed Arabic cultare— such as the xeparation of pharmacy and medicine—pessed over to the West. ‘By the mid.1th contury, when Frederick If, the ruler ofthe Kingdom of the Two Sicilie, codified the separate practice of pharmacy for the first ime in Europe, publie pharmacies had ecome relatively common in southern Europe. Practitioners of pharinacy had joined together within guilds, which sometimes included dealers in similar goods, such as spicers or grocers, or phiysicia ‘Arabic culture had returned classical scientific and medical knowledge to Europe. At centers such as Toledo and Salerno, the writings of the Grecks, which had been translated into, Arabic centaries before on the fringes of the old eastern half of the Roman Empire, were translated into Latin for the use of European scholars. Thus, at the emerging universities of Europe such as Paris(1150), Oxford (1167), and Salerno (1180), scholars discussed the works of the great’ medieal authorities such a Dioscorides, Galen, and Avicenna, ‘However, the debates on medicine among European aca- omies wore based on speculation, not abservation. Theirs wat ‘a philosophical pursuit, with no great impact on medical prac- tice, For significant change to occur in the use of druge, the scholastic approach had to be set aside and a more skeptical, observational methodology adopted. This new, experimental lage we now call the Renaissance THE RENAISSANCE AND EARLY MODERN EUROPE ‘The Renaissance. simply put, was the beginning of the modern period. Changes that had begun during the European Middle Ager, and wore stimulated further by contacte with other cultures, gained momentum. The burst of creative energy that ‘would result in our present shared culture ofthe West stemmed not from a single episode, but from a series of events, (CHAPTER 2: EVOLUTION OF PHARMACY 9 In 1453 Constantinople (Istanbul) fell to the conquering ‘Turks, and the remnants of the Greek schelarly community there fled west, carrying their books and knowledge with them. About that same time, Johann Gutenberg began printing, ‘with movable type, sterting an information revolution. Within ‘half century, Columbus discovered the New World, Vasco da Gama found the rea route to Indie that Columbus had sought, commerce based on money and banking was estab- lished, and syphilis raged through Europe. [t was a time for new ideas through reinterpretation of the old classical them ‘and through exploration on the high sea and in the laborator ‘The time was ripe for casting off the old concepts of diseases ‘and drugs of Galen. The new drugs that were arriving from far- off lands were unknown to the ancients. Printers, after fulfilling, the demand for religious books such as bibles’ and hymnals, turned to producing medical and pharmaceutical works, espe- cially those that could benefit from profuse and detailed illustra- tions. On the medical side, for example, this trend is exemplified in the anatomical masterworks of Andres Vesalius (1514-1564). For pharmacy, printing had a profound effect on the study of plant drugs, because illustrations of the plants could be re- produced easily. Medical botanists such as Otto Brunfels (1500-1534), Leonhart Fuchs (1501-1566), and John Gerard (1545-1612) illustrated their works with realiatie renditions of | plants, allowing readers to do serious field work or find the ‘Grugs needed for their practices, Among the most gifted of these investigators was Valerius Cordus (1515-1548), who also wrote ‘a work ia another popular genee—formula books. His Dispen- ssatorium (1516) became the official standard for the prepara- tion of medicines in the city of Nuremberg and generally is considered the first pharmacopeia. Although they were critical to the advancement of medical science, the nearly modern, precise works of Fucks and Vesal- ius did not influence the treatment of disease as much as the speculative, mystically tinged writings of an itinerant Swiss surgeon who dubbed himself “Paracelsus.” Born Philippus Aureolus Theophrastus Bombastus von Hohenheim in 1493, the year Columbus went on his second trip, this medical rebel represents well the combined attitudes of the common man, the scholarly physician, the practical surgeon, and the alchemist. The battles of Paracelsus against the static ideas of Galen, Avicenna, and other traditional authorities opened a window into the complicated mind of the Renaissance. As Erwin Ackerknecht observed in A Short History of Medicine, “Paracelsus is one of the most contradictory figures ofa contra ictory age. He waa more modern than moet of his contempo raries in his relentless and uncompromising drive for the new and in his opposition to bind cbedience to aushoritariaaismand books. On the other hand he was more medieval than most ofhis contemporaries in his all;pervading mystic religiosity. His writ- ings are a strange mixture of intelligent observation and mysti- cal nonsense, ofhumble sincerity and boasting megalomania.” Paracelsus was the most important advocate of chemically: prepared drugs from crude plant and mineral substances, yet he believed firmly that the collection of those substances should be determined by astrology. He stated, again and again, his total faith in observation while at the same time preaching the “doctrine of signature,” a belief that God had placed 2 sign on healing substances indicating their use against disease (eg, liverwort resembles a liver, so it must be {00d for liver ailments) An outspoken enemy of university-edueated physicians, Paracelsus denigrated their scholasticism and wrote his own works in his native language rather than in the traditional Latin. He harshly criticized pharmacy practitioners as vell, even though his advocacy of chemically prepared medicin« was to spark the growth of the modern pharmaceutical sci- fences. Chemical processes, especially distillation, empowered the follower of Paracelsus to isolate the healing principles of a drug, ite quintessence. Eventually, as the efficacy of some of these drags became known, they entered professional medicalaa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.immigrants from the Continent, where states often restricted pharmaceutical practice, expressed opposition to the legal Control of pharmacies. Many had come to North Ameriea to fpen their ovn shops, rather than wait years in their native lands for permission. nthe late 1860s the academie model of professionalism be- ing worked out by other so-called "new professions” such ax engineering attracted the attention of some pharmaceutical leaders. Using university degrees, plus state licensing or in- stitutional certification, these new professions set themselves apart fom other occupations as “communities of the compe- tent.” They sought to avoid the ordeals of the marketplace by putting a cognitive gap between their work and the publics Understanding. Theoretically, by controlling admissions to professional schools and raising examination standards, de- structive competition could he reduced or even eliminated LEGISLATION ‘The APhA responded to the movement ofthe late 1860s toward increased public protection and occupational security through law by publishing a model pharmacy act. Physicians and others concerned with the safe use of poisons and potent drugs had petitioned state legislatures for laws governing pharmacy. Ini- tally, pharmacists took @ negative view, reacting to the idea that physicians or bureauerats would gain authority over phar- macy practice via state inspectors or licensing beards. To ‘ensue that the profession's best interests would be protected, the APhA empowered a committee to draw up a model law. Refecting the ambivalent attitude of many pharmacists to. ward legal regulation, the APhA published and distributed their model law without endorsement. As small businessmen, pharmacists did not want outside restriction on their trade. During the 1870s state legislatures began considering ceamest pharmacy bills sponsored by nonpharmacists. Reacting to this trend, pharmacists organized statewide associations to coordinate support for their own bills, which were often ver- sions of the APhA model. Although not enthusiastic at first about regulation of their businesses, pharmacists wanted @ voice in the process. The eventual success oftheir efforts in the 1870s, 1880s, and 1890s evinced a changing attitude toward the pursuit of professionalism from the 186(s. ‘The bourdary hetween masters of the pharmaceatical art and mere store clerks, which had always been flimsy, was dix intograting Pharmacists sought new ways to demonstrate their competence and to separate themselves from ignorant drug sell cersand quacks. The evidence for this expertise, however, shifted away from individual achievement in the marketplace toward group identification and institutional certification. TRANSITION TO A MODERN PROFESSION ‘The period between 1870 and 1920 was transitional for both pharmacy and pharmaceutical education. Before the Civil Wat perhaps only 1in20 American pharmacists had finished formal Schooling in pharmacy, which had consisted of night courses to supplement apprenticeship training. With the passage of state Jaws requiring the examination ane registration of pharmacists from the 1870s on, pharmacy became part of the wave of pro- fessionalization sweeping across American society. The new professionals based ther claims of status on their diploma and licenses, not their preducts Pharmacy got caught up inthis trend, and evea though state laws did not require a pharmacy schoo diploma for Heensure ‘until the early 20th eentury, the prestige attached tothe sheep- skin attracted students tothe burgeoning numberof school, as public expectations inereased and “professional” became ® coveted ttle Pharmaccutical education around the turn of the century was related closely to practice as pharmacisteducators such as ‘Joseph Remington replaced the physicians and other nonphar ‘CHAPTER: EVOLUTION OF PHARMACY 13 macy practitioners who had dominated the earlier schonls. Stu- dents also had a wide range of possible educational experiences. + Short-term cram schools were available for these who just wanted to pase a state board exam. + Small, loal schools sprang up in medium size cities offering basic instruct and large diplomas for display. + The old-lin schools, affibated with loea! pharmaceutics! organi- zations, provided students with excellent practical edueation, plus fan opportunity to explore specialty areas, depending on te cl lege faculty. + Starting with the University of Michigan in 1858, sehools of pharmacy alibated themselves with state colleges and univers- ‘ies; a trend that altered the direction of American pharmacet cal education As part of larger university communities, these pharmacy schools aspired to the high standards of scholarship exhibited by established disciplines and other professions. The leaders of the university faculties helped transform pharmaceutical edu- cation from a vocational to a scientific orientation through Pharmacy programs that emphasized fulltime coursework and laboratory study. ‘During this period pharmacy’s part in health care salidified, the dispensing of medicines by physicians deslined. How. ever, the rise of the cut-rate drugstore and, more importantly, the chain drugstore, also oowurred during these 50 year, which further increased economic pressure on the profession. Bill, most pharmacists worked in their wn corner drug store, which became a fixture in American life withits shelves of patent medicines forall ils and a seda fountain for delighiful beverages; the proprieior, often called doc, atiended to the mi- nor aches and pains of customers or made chocolate sodas with equal skill Although the pharmacist relied on prescription com pounding for his professional identity, this provided only a small Fraction ofhis income. To proteet this independent and uniquely ‘American style of practice from the incursion oflarger retailers, the National Association of Retail Draggists (NARD) w: founded in 1898. At first the APhA weleomed and cocperat with he new aational organization, but the spit that eventually developed between the APhA, which was oriented to scientific and professional advancement, and NARD, which concentrated on the individual commercial success of owners, weakened the profession's voice in national affairs in the years to come. was an exciting time in medicine, with therapeutics un- dergoing a transformation. The germ theory of disease, cham pioned by laboratory scientists such as Louis Pasteur and Robert Koch, resulted in significant immunotogical advances in the 1880s and 1890s. Pasieur's rabies vaccine and Frail von Behring’s diphtheria antitoxin demonstrated that cures for infectious disoases could arise from the laboratory. Paul Ehriich transcended the biological effors of his predecessors when he introduced Salvarsan in 1910, the first chemothera- peutic agent. Although it fll short of Ehrich’ bullet, which could destroy microorg damaging the patient, Salvarsan did inspire others ta search for drugs with chemotherapeutic potential. Aside fom the biologicals, however, few ofthe drugs discovered during the late 19th and early 20th centuries had significant impact on the prevention or cure of disease. Industral research on érugs produced several new agents, such as the analgesic and antipyretic aspirin or the sedative chloral hydrate, that reduced the pain and sulfering associated With illness. Even though pharmacior sorved as important Outlets for sera, antitorins, and vaccines, mos ofthe medicines compounded or sold by pharmaciats around the turn of the century eased symptoms, rather than treated roa illnesses. 'As scientific pharmacolegy explained how drugs werked on a cellularandorgan system level, the concept of drags and their Actions held by professionals and laypeople diverged. The pub- lic clung to outdated ideas of humoralism augmented by a rmodicum of germ theory. Such beliefs made eonsumers suscep- tible to patent medicine advertising, which misled them into equating the effets of strong laxatives and analgesics with theaa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.Medisinalordnung Friedrichs II. Rine phormatiehistorische Studie (Eutin: Internationale Gesellschaft far Geschichte der Pharmazio, 1957). In he poriodicaliterature, not particularly the writings of Alfons Lutz, euch as “Der verschollene frih- salernitanische Antidotarius magnus - "and itsrich bibliogra- phy (new series, vol 16; Stuttgart: Veroffentlichungen der Internationalen Gesellschaft fur Geschichte der Pharmazie, 1960, pp 97-183}; also see the works of Rudolf Schmitr, such +... Apothekerstandes im Hoch und Spat-Mittelalter” (val 18; Stuttgart: Verofentlchungen der Internaticnalen Gesellschaft fur Geschichte der Pharmazie, 1958, pp 187-165) ard “Ueber deutsche mittelateriche Quellen zur Geschiehte von Pha marie und Medizin” (Deut Apotheker-Zig 1960; 100: 980). En- lish language studion of snunoal value and clarity include articlesby GE Trease, such as “The Spicers and Apothecaries of the Royal Household in the Reigns of Henry Il, Bdward I and Edward" (Nottingham Mediaeval Studiesi969;3: 19;abridged in Pharm J,4 April 1949, pp 246-248). A uniquely useful work is Sister Mary Francis Xavier [Welhoefer], Statutes ofthe Guild of Physicians, Apothecaries and Merchants in Florence (1313-1816, A Brief Commentary, with ar Introduction and ‘Transletion,” (unpublished PhD dissertation, University of Wisconsin, 1988), even though itis dated as to many details. On metieval European materia media, see Henry E Sigerist, Ma- teria Madica in the Middle Ages” (Bull Hist Med 1998; 7: 417), and his“Studien und Texte zur frikmittelalterlichen Rezeptlt: ratur” (ol 13; Leipzig: Studion zur Gosehichte der Medizin, 1923, pp 187M. Probebly the eerliest pharmacists texibook and ‘mantal hasbeen translated into German by Leo Zimmermann, Saladini de Aseulo.... Camperdium aromatariorum (Leipzig, 1919); for « Hebrew translation, see Suessmann Muntner, editor, Sefer ha-rokhim (Tel-Aviv: np, 1953). ‘On Modern Europe: For a reliable and concise medical overview, seo Erwin Ackerknecht, A Short History of Medicine (New York: Ronald Press, 1958); for detailed references, supple: ‘ment itwith Fielding Garrison, An Introduction to the History of Medicine, 4th ed Philadelphie: Londen: WB Saunders, 1929; ‘epublished 1960), noting ospaialy the bibliographic oxaays of ‘Appendix IL. Some international survey volumes on pharmacy, with particular reforence to the modem period, ae listed in Sonnedecker and Berman's Sone Bibliographic Aids for Histor ical Writers in Pharmacy (Madison, WE American Institute of the History of Pharmacy, 1958). A gap has been closed, mean while, by Leslie G Matthews, History of Pharmacy in Britain (Edinburgh and London: E & S Livingstone, 1962) and Cecil Wall, HC Cameron, and EA Underwood, A History of the Wor- shioful Society of Apothecaries of London, VolT: 1617-1815 (Lon- don: Oxford University Press, 1963). For those contemplating research in British archives, se [-Richmond, J Stevenson & A ‘Turton, eds, The Pharmaceutical Industry: A Guide to Histor cal Records (Buslington, VT: Ashgate, 2003) There is not yet 4 comprehensive, up-to-date history tha: deals with Buropean pharmacy; ibllographies, such aa those cited in the earlier sec tion on general literature guides, will yielé books and mono- graphs from particular topleal and national viewpoinis. For an example of e specialized topic, see Richard Palmer, ‘Pharmacy in the Republic of Venice," in The Medical Renaissance ef the Siateenth Century, A Weer, editor (New York: Cambridge Uni- versity Press, 1985); see aloo B Potesch editor, The Pharmacy Windows on History (Rocke, 1996). specialized book of note M.S. Conroy, In Health and Sickness: Pharmacy, Phormacist and the Pharmaceutical Industry in Late Imperial, Early Soviet ‘Russia (New York, Columbia University Press, 1984). Espe- cially rich ip Europoan history are the publications, 1927 tothe present, of the International Society for the History of Phar macy; « partial key has been published by Herbert ftugel, Die “Veroffentlichungen der Internationalen Geselischaf fur Geschichte der Pharmazie 1955-1965: Eine Bibliographic" (new series Bd 29; Stuttgart: Veroffentichungen der Internationalen Gesellschaft fur Geschichte der Pharmazie, 1967). ‘On the US: The standard volume in English, Kremers and Undang's History of Pharmacy, revised by Glenn Sonnedecker CCHAPTER2: EVOLUTION OF PHARMACY 17, (Philadelphia: Lippinestt, 1976), devotes approximately two- thirds ofthe main text to the United States, and its bibliogra- phies open up a wide range of other American literature. Note- ‘worthy are the anniversary issues of Druggists Cireular vol, Tanuary 1007 and Pharmaceutical Era vol 16, no 27, 91 De” ‘comber’ 1896). Seo also Glenn Sonnedecker, “Structare and Stress ofAmerican Pharmacy" (Pharm J, 14 April 1996, pp 3-8) A series of 18 historical articles on American pharmacy were published in J APiA during 2000, 2001, and 2002. Four papers covering a wide variety of American topies are contained in GJ Higby & BC Stroud, eds., Apothecories and the Drug Trade (Madison: American Insti ofthe History of Pharmacy. 2001) ‘The story of American pharmacy’s umbrella organization is told by Goonge Grifonhagen, 150 Years of Caring! A Pictorial Hix- tory ofthe American Pharmaceutical Association (Washington, DC: APhA, 2002). Pharmaceutical education is explored in depth by Robert A. Buerki, “In Search of Excellence: The First Century ofthe Ameriean Assoriation of Colleges of Pharmacy,” ‘Am Pharm Ea 63 (Fall Supplement 1999) 1-210. A useful bok at certain aspects of colonial American pharmacy can be found in Renats Wilson, Pious Traders in Medicine: a German Phar- rmaceutical Network in ighteenth-Century North America (Uni- versity Park, PA: Pennsylvania State University Press, 2000) Several different aspects of 1thcentary practice are considered by Gregory Highy, In Service to American Pharmacy: The Pro- fessional Life of William Procter, Jr Tuscaloosa: University of Alabama Press, 1902). A solid Biography of @ 20th-contury ‘American pharmacist is James Madison, Elf Lilly: A Life, 1685-1977" ndianapslis: Indiana Historical Society, 1989) Other valuable biographies include Michael A Flannery, John Uri Loyd: The Great American Eclectic (Cartondale: Southern Mlinois University Press, 1998) and Sabine Knoll-Schiize, Friedrich Hoffmann (1832-1904) ond the ‘Pharmaccutische Rundschau’ (New York: Peter Lang, 2008). Changes in the use and production of drugs are explored by John Harley Warner, ‘The Therapeutic Perapective: Medical Proctce, Knowledge, and Identity in Americ, 1820-1885(Cambridge: Harvard Univer- sity Prose, 186) and John P Swann, Academie Scientists and the Phermaceutical Industry: Cooperative Research in ‘Twentieth: Century America Baltimore: ohne Hopkins Univer- sity Press, 1988). See also John Parascandola, The Development of American Pharmacology: John J. Abel and the Shaping of a Discipline (Baltimore: Johns Hopkins University Press, 1992) and Harry M Marks, The Progress of Experiment; Science and Therapeutic Reform in the United States, 1900-1990 (Cam- bridge, UK; New York: Cambridge University Press, 1997). Short histories of individual drugs are provided by Walter Sneader, Drug Prototypes and Their Exploitation (New York: ‘ohn Wiley, 19961 For a contemporary ase of historieal argu ‘ments in poly analysis, se a series of articles written by RW. Holland & CM Nimmo on “Transitions in Pharmacy Practice,” that appear in the Amer J Health-System Pharm 56 (1999): 1758-64, 1981-7, 2254-41, 2458-62, 67 (2000) 64-72. A usoful bibliography that is stil in prints by George Griffenhagen, Bib ography of Papers Published by the American Pharmaceutical ‘Associaton that were presented before the Association's Section ‘on Historical Pharmacy, 1904-1967 (Madison, WI: American In- stitute ofthe History of Pharmacy, nd), which includes subject and author indexes; although it emphasizes American history, it isby no means restricted to it The “Pharmacy” section ofthe annual bibliography inthe Bulletin of the History of Medicine at ‘one time offered an important key ta the literature, which wax cumulated in Bibliography of the History of Medicine of the United States and Canada, 1989-1960, Genovieve Miller, editor ‘Baltimore: Johns Hopkins University Press, 1964). See also other bibliographies listed earlier in the section on general li erature guides. Also noteworthy is the “Bookshelf” section of Pharmagy in History, « quarterly ofthe American Institute of the History of Pharmacy (Madison, WI); and the sections on “History and Ethics," “Sociology and Eeonomie,” and “Litera- ture" in the ongoing International Pharmaceutical Abstracts (Washington, DC: American Society of Hospital Pharmacist)aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.Preamble Pharmacists are health professionals who assist individu- alsin making the bes: use of medications. This Code, pre- pared and supported by pharmacists, is intended to state publicly the principles that form Uefundamental basisof the roles and responsibilities of pharmacists. ‘These prin- ciples, based on moral obligations and virtues, are estab- Ushed to guide pharmacists in relationships with patents, professionals, and society. 1. A pharmacist reapecta the covenantal relationship be- tween the patient and pharmacist. Considering te paten-phamacit rations asa covenant means that maral obligations in response to the gift of trust freshedivom socey. nretan forts git pharmacist promises help individuas achieve optimum benefit rom their medications, to be ‘Corti to thelr welfare ancora el trast IL. A pharmacist promotes the good of every patient ina caring, compassionate, and confidential manner. {A pharmacist places concern forthe wel-beg ofthe patient atthe ceruer of professional practice. In doing s0, a pharmacst considers ‘eed tase by the pation’ arwellas howe definedby heatracience. A [Pharmacist is dedicated to protecting the dignity ofthe patent. With faring atte and s compassionate spits pharmack focus on ‘serving ke patent na private and confidential anne. TIL A pharmacist respects the autonomy and dignity of each patient. promotes the right ose determination and recognizes indvidon eros by ecouri patent partiae in decisions about thar health A pharmacist communicates wit patients interns that are understandable. In all cases a pharmacist respects persoral and cultural diferences among patents Code of Ethics American Pharmacists Association CHAPTER 2: ETHICS AND PROFESSONAUSM 21 IV. A pharmacist acts with honesty and integrity in profes- sional relationships. ‘A pharmacist ha aduty otllthe truth and to act wih conviction of | constience. A pharmacist avoids tory practices, behavior o | ‘work conditions that impr professional Jaden, snd artlons that Compromise deacation wo ve bes iverests of paris V. A pharmacist matnains professional competence. A pharmacist has a duty to maintain knowledge and ables as new ‘medieators, devices, and teehndlogies became available and as fealth Information advances VI._A pharmacist respects the values and abilities of col- leagues and other health professionals. ‘When appropriate, a pharmacletanks forthe consultation of cot leagues or other health professcnas or refers the patient. A pharma- at kn ‘that colleagues and other heath professionals may ifferin the belles and values they appy tothe cae ofthe patient. VII. A pharmacist serves individual, community, and soci- etal needs, ‘The prinary obligation of a pharmacist i to individual patents. However, the obligations oa ptarmacit tay at snes extend yon the Individual to the community and society. Ie these situations, the Dpharmaclat cognac: the raponsiiltics tt actompany these osiga onsand acts accordingly. VII. A pharmacist seeks justice in the distribution of health ‘Wen health resources are located, a pharmacist i fair and equ cable balareing te needs of patents ad sore. Figure 3-1. Code of ethic (Originally published in “Code of Ethics for Phamacis.” Am J Healt-Syst Pham 1995: 52: 2131. © 1995, American Society of Health-System Pharmacists, Inc All ights reserved. Reprrted with permission.) ‘The second characteristic of a professional is 2 set of specific ‘attitudes that influence professional behavior. The basic com- ponent of this set of ettitudes is altruism, an unselfish concern for the welfare of others: “The professional man, it has been said, does not work in order to be paid: he is paid in order that he may work. Every decision hhe makesin the course f his career is basedon his sense of what is right, not on his estimate of what is proftable”* Professionals are concerned with matters that are vital to the ‘health or well-being of their clients, The practitioner employs highly specialized technical knowledge, which the patient or client does not possess. Both the client's lack of knowledge and the vital nature of professional services provide the profes- sional with an opportunity to exploit the client. The conse- ‘quences of such exploitation are severe. The smocth functioning of the professions requires that the practitioner must consider the needs of the patient as paramount, relegating his or her ‘own material needs to an inferior posito Social sanction, the third characteristic of a professional, i a resultant effect of the two characteristics already discussed. Whether an occupation is considered to be a profession de- pends, to a large degree, on whether society views it as such. One measure of social sanction is the granting of exclusive rights of practice through the licensing power of the state, Licensing not only attempts to protect the public from in- competent practitioners, but also frequently creates a relation- ship of trust between society and the professionals, because ‘within the sphere of professional activities, the professional ex- ercises an authoritative power over pationts. As explained by Greenwood, “(he professional dictates what is good or evil for the client, ‘who has no choice but to accede to professional judgment. Here the premise is that, because he [or she] lacks the requisite theo- ratieal background, the elient eannot diagnose his [or hor] own ‘needs or discriminate among the range of possibilities for meet- ing them." ‘Theextent of the public's trust is a measure of the degree of so- ial sanction, and this is evident in society's permitting the ex- cercise of sovereign power over professional matters. Given the ‘egal monopoly inherent in professional licensing, the failure of society ta impose further centrale on the profession is sanction. ing, by implication, the profession's performance and selfregu- lation. Thus, profeaeions have evolved as occupations connected with high status. The functional relationship of professions toaa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.aa You have either reached a page that is unavailable for viewing or reached your viewing limit for this book.grants approval for its release. Confidentiality and privacy have received a great deal of attention recently with the pas \ge and implementation of the Health Insurance Portability and Accountability (HIPAA) Act. ‘Though often used interchangeably, the terms confidential ity and privacy do differ. A violation of privacy occurs in situa- tions where personal information is obtsined/revealed by an in- dividual who has not been granted access to such information, A compater hacker would be an example, Conversely, a viola tion of confidentiality results from the inappropriate release of personal information to others by a person, such as a health care professional, who has been granted access to such information Tn healthcare, it ix somotimes unclear which members of the health care team may have access to confidential medical records without the express consent of the patient, Should pharmacist or physical therapist earing for a patient have the same access to medical records that is afforded the patient's physician or hospital nurse? Another difficult ethical situation wolves a patient who explicitly expresses a desire not to have formation divulged to a member of the health care team. For example, a patient may tell a pharmacist of her decision to al- ter her prescribed therapeutic regimen, but request that the pharmecist not disclose this information to her physician. Confidentiality has the same two ethically justifiable ex- ceptions as does the principle of sutonomy, the harm princ- ple, and weak paternalism. As with autonomy, a pharmacist ‘may be ethically justified in violating the confidentiality of @ patient when keeping information private may harm others (harm prineple) or when the patient lacks autonomy (weak paternelism) Beneficence/Nonmaleficence Ronoficence and nonmaleficence are ethical principles that are, in a sense, complimentary to one another. Beneficence indi cates that you act in a manner to do good. Nonmaleficence refers to taking due care or avoiding harm. Beauchamp and Childress compare these related principles ‘The word nonmaleficence is sometimes used more broadly to inelude the prevention of harm and the removal of harmful con- ditions. However, because prevention and removal require pos- itive acts to assist others, we include them under beneficence along with the provision of benefit. Nonmaleticence is restricted to the noninflietien of harm. Fidelity Fidelity requires that pharmacists act in such a way as to demonstrate loyalty to their patients. A type of bond or promise is established between the practitioner and the patient. This professional relationship places on the pharmacist the burden of acting in the best interest of the patient, Pharmacists have an obligation of fidelity to all their patients, regardless of the length of the professional relationship. In community phar- macy, for example, practitioners have the same obligation to show fidelity to an oceasional patient as they have for a regular vastomer ‘The depth of the fidelity relationship between the pharma- cist and patient is a topic of ongoing discussion among phar. ‘macy ethicists, Two forms of fidelity are frequently alluded to: covenantal and contractual, Covenanial fdelity is often de- scribed as an intimate and spiritual commitment between indi viduals. Examples would inclade the fidelity of marriage and the fidelity between a member ofthe elergy and his or her con- gregation, Conversely, contractual fidelity does not involve & level of commitment beyond that owed another as the result of a binding agreement. An example of this form of fidelity would be the relationship one might have with a eontractor such as a plumber or electrician. What remains in dispute is where the (CHAPTER: ETHICS ANO PROFESSIONALISM 25, pharmacist-patient relationship lies along the continuum be- tween covenant and contract Verscity. bbe honest in their dealings with patients. There may be times when the violation of veracity may be ethically justifiable (as with the use of placebos), but the violation of this principle for ‘non-patient-centered reasons would appear to be unethical. In 1 professional relationship based upon professional fidelity, pa- spect that their pharmacist will be Distributive Justice ibutive justice refers to the equal distribution of the bene- fits and burdans of society among all members of this socioty. We often think of distributive justicein terms of our health care delivery system. This principle is frequently used as a jastfica- tion for providing health care as a right to all Americans. Even though justice instructs that pharmacistsdemonstrate an equivalent amount of care, pharmacists do not always pro- vide care with equal fervor to all patients. Sadly, issues such as the patient’ socioeconomic status often impact the level andi tensity of eare provided by health care professionals. Medicaid patients are sometimes provided a much lower quality of care than a patient who is a cash-paying customer or who has a full- coverage drug benefits plan. All too often, the eare provided by a health care professional is viewed in terms ofthe personal re- ‘ward for the professional, euch ax the level of reimbursement the care is likely to reap. Justice demands that the focus be on patients and theirmedical needs, not on the financial impact on the health eare professional." ETHICAL CODES Ethical principles and rules that apply to medical practice and. research, such as autonomy, beneficence, and justice, have long served as the basis for a system or code of ethical conduct. ‘Western medical ethics is primarily based on the Hippocratic code attributed to the Greek philosopher Hippocrates, 5th cen- ‘tury RC Medicine (American Medical Association) and phar- macy (Philadelphia College of Pharmacy) developed codes of conduct for their respective practitioners in 1848. As Montagne notes, “the guiding principles of these eodes were a respect for human life aad service to humanity.” The Holecaust during World War Il, and the subsequent Nuremberg trials, would prompt the first major development of a code dealing speci cally with experimentation on human subjects. ‘Subsequent to Nuremberg, several other codes of medical ethics were established. In 1949, the World Medical Association drafted the Geneva Convention Code of Medical Ethics, a eon- temporary version of the Hippocratic oath. In the 1960s, the ‘same organization established an ethical code on clinical re- search. In 1984, the Declaration of Helsinki was adopted based ‘upon the Nuremberg principles, and it was further revised in 1975. In 1972, the American Hospital Association issued a Statement ona Patient's Bill of Rights. In 1977, the Declaration of Hawaii provided ethical guidelines for clinical research in psychiatry. ‘Ethical cotes provide health care professionals with ethical principles and standards by which to guide their practice, How- ever, ethical principles and codes cannot hope to provide health care professionals with answers to every moral question that ‘may arise in the course of their practice. Ethical questions in health care involve decision-making that is usually situation- specific. The purpose of such principles and codes is not to pro- vide practitioners with right and wrong answers, but to offer them a framework to use when faced with ethical questions. As